Clinical Research Directory

Misocholic Tablets for Non-Viral Elevated Liver Enzymes

Elevated liver enzymes are common laboratory abnormalities that may result from alcohol-related liver disease, drug-induced liver injury, or non-alcoholic fatty liver disease (NAFLD). Persistent elevation of liver enzymes may indicate ongoing hepatocellular injury and increase the risk of progressive liver disease. Current management primarily focuses on treating the underlying cause and providing supportive care, while evidence for effective hepatoprotective therapies remains limited. This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of Misocholic Tab, a film-coated herbal medicine, in adults with mild to moderate elevation of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) associated with alcohol-related liver disease, drug-induced liver injury, or non-alcoholic fatty liver disease. Eligible participants will be randomly assigned in a 1:1 ratio to receive either Misocholic Tab or matching placebo for 30 days. Both groups will receive standard background therapy with silymarin. The primary objective is to compare the change in serum ALT and AST levels from baseline to Day 30 between the two treatment groups. Secondary objectives include evaluating the proportion of participants whose liver enzyme levels return to the normal range and assessing the safety of Misocholic Tab through clinical evaluation, laboratory testing, and monitoring of adverse events.

Prevalence and Prognosis of Drug-Induced Liver Injury

Drug-induced liver injury (DILI) is an important cause of acute liver damage that occurs when prescription medications, over-the-counter drugs, herbal products, or dietary supplements harm the liver. DILI can range from mild abnormalities in liver enzymes that cause no symptoms to severe conditions such as acute liver failure, the need for an urgent liver transplant, or death. Diagnosing DILI is often challenging because it shares symptoms with many other liver diseases, and there are currently no single specific blood tests to confirm it. There is limited data regarding the prevalence, causative agents, and clinical outcomes of DILI among patients in Upper Egypt. The main purpose of this study is to: 1. Determine the hospital-based prevalence of DILI among adult patients attending Al-Rajhi Liver Hospital, Assiut University Hospitals. 2. Identify the most common medications, herbal preparations, and supplements causing liver injury. 3. Categorize the patterns of liver injury (hepatocellular, cholestatic, or mixed) using standardized biochemical calculations (R-ratio). 4. Evaluate patient outcomes and identify clinical and laboratory factors that predict unfavorable outcomes, such as acute liver failure, liver transplantation, or death. The study is an observational study conducted over a two-year period using two approaches: * A retrospective chart review of adult patients diagnosed with DILI during the first year. * A prospective follow-up of consecutive adult patients who present with DILI during the second year. Participants will receive standard medical care as directed by their treating physicians. Routine medical data, laboratory tests, imaging results, and treatment details will be recorded and analyzed to help improve the early detection, prevention, and management of DILI in clinical practice.

A Real World Study of Polyene Phosphatidylcholine Injection for the Prevention and Treatment of DILI in Patients With Malignant Hematological Diseases

This is a retrospective, multicenter real-world observational study. Its main goal is to find out if Polyene Phosphatidylcholine Injection works to treat drug-induced liver injury (DILI) in adults with hematologic malignancies, and to check if the drug is safe. It also aims to answer these key questions: Does Polyene Phosphatidylcholine Injection help prevent DILI in people with hematologic malignancies? How effective and safe are different combinations of Polyene Phosphatidylcholine Injection with other liver-protective drugs for DILI? Which DILI treatment plan offers better value for money? Who can take part? Participants must meet all these criteria: 18 years or older (no gender restriction) Diagnosed with a hematologic malignancy (such as leukemia, lymphoma, or multiple myeloma) Received at least one cycle of chemotherapy that may harm the liver Used Polyene Phosphatidylcholine Injection to treat or prevent DILI (alone or with one/two specific liver-protective drugs: Magnesium Isoglycyrrhizinate Injection, Glutathione Injection, Ademetionine 1,4-Butanedisulfonate Injection/Tablets, Ursodeoxycholic Acid Oral Formulation, or Bicyclol Tablets) Had liver function tests within 7 days before starting treatment and at least once after starting treatment What will the study involve? Researchers will look back at medical records of eligible participants treated on or before November 30, 2025. They will collect and analyze: Participants' basic information (age, gender) and disease details Details about Polyene Phosphatidylcholine Injection use (dose, frequency, duration) Liver function test results (including alanine aminotransferase \[ALT, a liver enzyme that rises when the liver is injured\], aspartate aminotransferase \[AST\], total bilirubin \[TBIL\], and other related indicators) at different time points (3 days, 7 days, 14 days, 21 days, 30 days, 60 days) after starting treatment Any unwanted health issues (adverse events, AEs) during treatment and how they were managed Costs related to treatment (drug fees, test fees, AE management fees) What are the key things researchers will measure? Main measure: How well ALT levels improve 7 days after starting Polyene Phosphatidylcholine Injection (defined as ALT dropping by more than 50% or returning to normal) Secondary measures: Improvement in liver function indicators at other time points (3 days, 14 days, 21 days, 30 days, 60 days) How well the drug prevents DILI (how often DILI occurs and how severe it is) Differences in effectiveness and safety between different drug combinations Which treatment plan is more cost-effective

Role of N-Acetylcysteine in Non-Acetaminophen-Induced Acute Liver Failure

Acute liver failure (ALF) is a serious condition in which the liver suddenly stops working, often leading to life-threatening complications. While N-Acetylcysteine (NAC) is widely used to treat ALF caused by acetaminophen overdose, its benefits in ALF due to other causes, such as viral infections or drug reactions, remain uncertain. This study is a randomized controlled trial designed to investigate whether NAC can improve survival rates and reduce hospital stays in patients with non-acetaminophen-induced ALF. Participants will be randomly assigned to receive either NAC along with standard supportive care or standard supportive care alone. The study will measure survival rates, hospital stay duration, and improvement in liver function tests. By exploring NAC's potential benefits beyond acetaminophen-related cases, this research aims to provide evidence-based guidance on how to better manage patients with ALF from other causes.

Screening of Susceptibility Genes for APAP Induced Drug Induced LIver Injury in ChiNese Population: a Case-control Study

Acetaminophen (APAP) is the most commonly used NSAIDS in clinic, and it is also a common cause of drug-induced liver injury (DILI). In 2012, the proportion of DILI caused by APAP in the United States was 51%, while in Asia, it was only 7.10%. Previously, a small cohort study in the United States screened for some of the susceptibility genes for DILI due to APAP by the Genome wide association study (GWAS) method. However, the genetic susceptibility loci based on the US cohort were not applicable to the Chinese population. Therefore, we make a study design include Chinese population who ingested APAP and divided them into case group and control group according to the occurrence of DILI. We hope to be able to find the root of differences at the genetic level and explore new pathogenic mechanisms.